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Scope of the Report

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Executive Summary

Chapter One: The Latest Developments of API Sourcing and Contract Manufacturing in China

Summary
1.1 Introduction
1.2 What happened in recent two years to the Chinese CMO and API manufacturing industries?
1.3 Analysis of the consequences of the quality incident and the impact of the financial crisis
1.3.1 Major pharma companies have changed their API sourcing pattern in China
1.3.2 Global regulatory agencies are also tightening up policies on quality control of imported APIs and generic drugs
1.4 What is the problem with Chinese API suppliers?
1.5 What improvements have been made since the quality incident?
1.5.1 Chinese government has revised cGMP standard and started implementing the new policy
1.5.2 FDA setting up offices in China to strengthen the inspection on Chinese API suppliers
1.5.3 Improvements made by Chinese API suppliers and CMOs
1.5.4 Foreign companies rushing to China to help Chinese companies upgrade their quality control system and management
1.5.5 Chinese companies expanding their presence in the Western markets
1.6 Reactions of the global pharma industry to the series of improvements
1.6.1 Western pharma companies still sourcing APIs in China
1.6.2 Recent market reactions to the Chinese-made APIs
1.6.3 Indian companies increasing sourcing of APIs and pharma intermediates in China

Chapter Two: Current Market Size, Service Capability and Key Players

Summary
2.1 Introduction
2.2 Current market size and service capability of Chinese CMO industry
2.2.1 Current market size of Chinese CMO industry
2.2.2 How to compare it with global CMO market
1. Current market size of global CMO industry
2. Current market size of Asian CMO industry
2.2.3 Current service capability of Chinese CMO industry
2.3 Current market size and service capability of Chinese API industry
2.3.1 Current total market size of Chinese API industry
2.3.2 Current market value of Chinese-made APIs marketed overseas
2.3.3 How to compare it with the global API market
1. Current market size of global API industry
2. Current market size of Asian API industry
2.3.4 Current manufacturing capability and capacity of Chinese API industry
2.3.5 Current service capability of Chinese companies in API manufacturing of developmental drugs
2.4 Case studies: Key players of Chinese API industry

Chapter Three: How to Effectively Conduct API Sourcing and Outsourcing in China

Summary
3.1 Introduction
3.2 Analysis of the weakness of Chinese API makers, issues associated with the Chinese API supply chain and solutions of how to overcome them
3.3 Classification of Chinese CMOs and API suppliers
3.4 Analysis of the key differences between the Chinese cGMP and the Western cGMP
3.5 What API quality standards are followed nowadays by Chinese API makers?
3.6 Analysis of the differences in business principles between Chinese companies and their Western counterparts and practical advices of how to avoid pitfalls in sourcing/outsourcing in China
3.6.1 Differences in business conduct between the West and the East
1. Long-term business development goals versus short term business development goals
2. Assumed responsibility versus required responsibility
3. Consistency versus randomness
4. Business relationship versus personal relationship
5. Summary of the characteristics of Chinese culture in business conduct
3.6.2 Two approaches in sourcing/outsourcing APIs in China
3.6.3 How to avoid pitfalls in sourcing/outsourcing APIs in China
3.7 How to set criteria for choosing a CMO and/or an API supplier in China
3.8 Strategies for effective collaboration with Chinese companies
3.9 Advices to small biotech companies outsourcing in China

Chapter Four: Future Development of Chinese API and Contract Manufacturing Industry

Summary
4.1 Introduction
4.2 Analysis of external drivers of future growth of Chinese API and contract manufacturing industries
4.2.1 Analysis of the demand for APIs of marketed drugs
4.2.2 Analysis of the demand for contract manufacturing of APIs of developmental drugs
4.3 Analysis of internal drivers of future growth of Chinese API and contract manufacturing industries
4.3.1 Improvements in technical capability and product quality control
4.3.2 China is implementing the new cGMP standard which is closer to that implemented by the EMEA
4.3.3 On-going nationwide healthcare reform
4.3.4 More investors interested in investing in Chinese CMOs and/or API suppliers
4.4 Market development forecast of Chinese API and contract manufacturing industries
4.4.1 Market growth forecast of Chinese CMO industry
4.4.2 Market growth forecast of Chinese API industry
4.4.3 Future growth forecast of Chinese API export industry
4.5 How to compare them with the future growth of global markets
4.5.1 Future growth forecast of global CMO industry
4.5.2 Future growth forecast of Asian CMO industry
4.5.3 Future growth forecast of global API market
4.5.4 Future growth forecast of Asian API market
4.6 Future growth pattern of Chinese API and contract manufacturing industries
4.6.1 More Chinese-made APIs and finished drugs will be marketed in the well regulated markets
1. Market growth forecast of Chinese-made dosage form medicines marketed overseas
2. How to compare with the same industry sector in India
4.6.2 Major pharma companies will license generic drugs from Chinese companies and market them worldwide
4.6.3 More consolidations
4.6.4 Contract manufacturing of biologic APIs will gradually grow in China
4.7 Key issues Chinese API suppliers and CMOs will still face in the near future
4.7.1 Fast rise of labor cost
4.7.2 Higher standards of product quality and environment protection
4.7.3 Abiding by the international rule of the game 4.7.4 Competition from neighboring countries

Profiled Companies

Research Methodology

About JZMed, Inc.

List of Tables

Table 1. Comparison of market changes in Chinese API export sector between 2008 and 2009
Table 2. Major pharma companies expanding their manufacturing facilities or building new ones in China
Table 3. Major global CMOs or API makers expanding their manufacturing facilities or building new ones in China
Table 4. Chinese companies improving quality control in their API production
Table 5. Western companies entering the Chinese market to help upgrade quality control system and management in Chinese API manufacturing and sourcing industry
Table 6. Chinese companies expanding their presence in the Western markets
Table 7. Examples of Western pharma companies currently still sourcing APIs or pharma intermediates in China
Table 8. Examples of Western pharma and biotech companies currently having collaborations with Chinese counterparts
Table 9. Examples of Indian companies currently sourcing pharma products in China
Table 10. Current market size and development history of Chinese CMO industry
Table 11. Current market size and development history of global CMO industry
Table 12. Comparisons of CMO market sizes between China and India (2007-2009)
Table 13. Current market value and growth history of Chinese API industry
Table 14. Current market size and growth history of Chinese API export industry
Table 15. Analysis of distributions of global API market in 2009
Table 16. Current market value and growth history of global API industry
Table 17. Current market value and growth history of global merchant APIs (both generic drugs and innovative drugs)
Table 18. Analysis of the contributions of Asian countries to the global merchant API industry
Table 19. Chinese API suppliers and the total number of their registered APIs (DMFs/EDMFs/COS's)
Table 20. Chinese API suppliers focusing on cancer medicines
　　　　　　(Including the list of their cancer drug APIs and contact information)
Table 21. Chinese companies that have FDA/EMEA certified cGMP facilities
　　　　　　(including their contact information)
Table 22. Comparison of different approaches to product quality management between Chinese companies and Western companies
Table 23. Analysis of current issues in Chinese API supply chain and solutions to overcome them
Table 24. Current top tier professional CMOs in China
　　　　　　(including their contact information)
Table 25. Current second tier professional CMOs in China
　　　　　　(including their contact information)
Table 26. Current top tier Chinese API suppliers
　　　　　　(including their contact information)
Table 27. Current second tier Chinese API suppliers
　　　　　　(including their contact information)
Table 28. Major characteristics of Chinese business principles
Table 29. Examples of Chinese API makers or drug companies improving their manufacturing capability
Table 30. Chinese companies able to manufacture high potency APIs
Table 31. Examples of Chinese CMOs or API makers that recently received financial investments
Table 32. Future market growth forecast of Chinese CMO industry
Table 33. Future growth forecast of total output of Chinese API industry
Table 34. Market growth forecast of Chinese-made APIs marketed overseas
Table 35. Comparison of market sizes between Chinese CMO industry and global CMO industry
Table 36. Future growth forecast of global CMO market
Table 37. Future growth forecast of global API market
Table 38. Future growth forecast of global merchant API markets of generic and innovative drugs
Table 39. Future growth forecast of Asian merchant API market
Table 40. Current market value and future growth forecast of Chinese-made dosage form medicines marketed overseas
Table 41. Current market value and future development forecast of Indian-made dosage form medicines marketed overseas
Table 42. Latest examples of consolidations in Chinese API industry
Table 43. Chinese companies able to manufacture biologic products

List of Figures

Figure 1. Quarter-over-quarter market development trend of Chinese CMO industry
in 2008 and 2009
Figure 2. Current market size and development history of Chinese CMO industry
Figure 3. Analysis of current global demands for API manufacturing of both small molecule and macro compound-based drugs
Figure 4. Current market size and growth history of global CMO industry
Figure 5. Current CMO market size comparison between China and India
Figure 6. Current market value and growth history of Chinese API industry
Figure 7. Actual development history of Chinese-made APIs marketed overseas
Figure 8. Current market value and growth history of total global API industry
Figure 9. Current market sizes and growth history of global merchant APIs (both generic drugs and innovative drugs)
Figure 10. Summary of current state of Chinese API manufacturing industry
Figure 11. Summary of current production capacity of Chinese API industry
Figure 12. Major pharma companies having manufacturing facilities in China
Figure 13. Case study on fast growing Zhejiang Hisun Pharmaceutical Co., Ltd.
Figure 14. Case study on fast rising Zhejiang Huahai Pharmaceutical Co. Ltd.
Figure 15. Classification and rating of professional Chinese CMOs
Figure 16. Classification and rating of Chinese API suppliers
Figure 17. Criteria for effectively choosing Chinese CMOs and API suppliers
Figure 18. Advices of how to effectively source APIs in China
Figure 19. Growth trend of Pfizer's manufacturing outsourcing
Figure 20. Summary of future growth drivers of Chinese API and contract manufacturing industry
Figure 21. Future growth forecast of Chinese contract manufacturing service industry
Figure 22. Future growth forecast of total output of Chinese API industry
Figure 23. Future growth forecast of Chinese-made APIs marketed overseas
Figure 24. Future growth forecast of global CMO market
Figure 25. Future growth forecast of Asian CMO market
Figure 26. Future growth forecast of total global API output
Figure 27. Future growth forecast of global merchant API markets of generic and innovative drugs
Figure 28. Summary of future development trend of API markets in North America and Western Europe
Figure 29. Future growth forecast of Asian merchant API market
Figure 30. Future growth forecast of Chinese-made dosage form medicines marketed overseas
Figure 31. Future growth forecast of Indian-made dosage form medicines marketed overseas